ACNE CLEANSING- salicylic acid gel

Acne Cleansing by

Drug Labeling and Warnings

Acne Cleansing by is a Otc medication manufactured, distributed, or labeled by KitavaMD, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Salicylic Acid 1%

Purpose

Acne Treatment

Use

For external use only

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Cleanse skin thoroughly before applying this product
• Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or directed by a doctor
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive Ingredients

Disodium Cocoamphodiacetate, Water, Sodium Lauroyl Lactylate, Decyl Glucoside, Salix Nigra (Willow) Bark Extract, Phenoxyethanol, Melaleuca alternifolia (Tea Tree) Leaf Oil, Ethylhexylglycerin, Ascorbyl Palmitate, Glycerin, Camellia Sinensis (Green Tea) Leaf Extract

Package Labeling:

INGREDIENTS AND APPEARANCE

ACNE CLEANSING 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72503-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
WATER (UNII: 059QF0KO0R)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TEA TREE OIL (UNII: VIF565UC2G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72503-000-00	120 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/01/2018

Labeler - KitavaMD, Inc (074709983)